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Saturday, October 28, 2017

OCT 28, 2017PARADIGMS data also show patients treated with Gilenya had significantly fewer new brain lesions vs. those on interferon beta-1a

Currently there are no specifically approved disease modifying therapies for children and adolescents with MS, a population at high risk of long-term disability

MS is a highly debilitating disease which touches every aspect of young patients' daily lives, from school performance to family relations and friendships

The digital press release with multimedia content can be accessed here:

Basel, October 28, 2017- Novartis today announced full results from the positive Phase III PARADIGMS study, investigating the safety and efficacy of Gilenya® (fingolimod) vs. interferon beta-1a, in children and adolescents (ages 10 to 17) with multiple sclerosis (MS). Treatment with oral Gilenya resulted in an 82% reduction in the rate of relapses (annualized relapse rate) over a period of up to two years, compared to interferon beta-1a intramuscular injections (p <0.001)[1]. PARADIGMS is the first ever controlled, randomized trial specifically designed for pediatric MS. The results have been presented at the 7th Joint European and Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) meeting on October 28, 2017 in Paris, France.

"Pediatric MS patients experience more frequent relapses and are more likely to accumulate physical disability at an earlier age than patients diagnosed as adults," said Dr. Tanuja Chitnis, Principle Investigator for PARADIGMS and Director of the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston, US, and Scientist, Ann Romney Center, Brigham and Women's Hospital, Boston, US. "Yet, current therapies are limited to drugs that have not been tested in a controlled manner in this age group. PARADIGMS was uniquely designed for this patient population. Its results signify an important step towards a potential new treatment that could improve the lives of these young patients."

Additional data from the study demonstrated:

A significant reduction in the number of new / newly enlarging T2 and Gd-T1 lesions in the brain of Gilenya treated patients compared to those treated with interferon beta-1a, as measured by magnetic resonance imaging (MRI)[1]. The number and volume of lesions are associated with increased relapses and disability progression[2].

Individuals treated with Gilenya had significantly less brain shrinkage (measured by MRI as brain volume loss), compared to those treated with interferon beta-1a[1]. Brain shrinkage in adults is associated with the loss of physical and cognitive function­[3].

The safety profile of Gilenya was overall consistent with that seen in previous clinical trials, with more adverse events reported in the interferon group[1].

"There is already substantial evidence that Gilenya is an effective treatment that improves long-term outcomes for adults with relapsing MS. We are delighted that PARADIGMS has shown such meaningful benefits for children and adolescents with MS," said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. "This pioneering study demonstrates our continued commitment to providing new treatment options to MS patients with the highest need. We look forward to working with health authorities and preparing for submission."

Gilenya is not currently approved for the treatment of pediatric MS. Novartis is working on submission with health authorities worldwide.

Genentech,
a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that
new OCREVUS® (ocrelizumab) data are being presented at the 7th Joint
European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) –
Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)
Meeting in Paris, France. The data presented showcase clinical advances around
underlying disease activity and disability progression in relapsing and
progressive forms of multiple sclerosis (MS), through the exploration of newly
emerging endpoints and precision monitoring.

OCREVUS
significantly reduced the proportion of people with RMS who experienced
Progression Independent of Relapse Activity (PIRA) in a post-hoc analysis
compared to Rebif® (interferon-beta 1a). This effect was particularly seen
in those who were potentially at higher risk of progressive disease course
based on their baseline Expanded Disability Status Scale (EDSS). Specifically,
in this analysis, OCREVUS treatment reduced the risk of PIRA by 25 percent and
23 percent confirmed at 12 and 24 weeks, respectively (p=0.008 and p=0.039,
respectively).

PIRA
is a newly emerging MS endpoint intended to measure an increase in disability,
which is related to underlying disease activity in RMS. These data were
generated through a post-hoc analysis of more than 1,600 people randomly
assigned to treatment in OPERA I and OPERA II, and assessed for PIRA, as
measured by cCDP. cCDP is a measure of the risk of a person’s physical
disability getting worse and is based on three measures of physical disability
– confirmed disability progression, walking speed and upper extremity function.

“These
new analyses of data from the large controlled studies with OCREVUS help
advance our understanding of how, in relapsing MS, the disease may progress independent
of relapses. These insights have implications for daily decisions made together
with patients,” said Ludwig Kappos, M.D., chair of the Department of Neurology,
University Hospital, Basel, Switzerland. “Even without experiencing relapses,
people with RMS may still have underlying disease activity, which can cause
irreversible decline in their mobility and day-to-day quality of life.
Recognizing and understanding this process supports early indication of more
efficacious treatment.”

A
platform presentation, also highlighting underlying disease activity, showed
that a new algorithm using conventional MRI can be used as a possible biomarker
to automatically detect Slowly Evolving Lesions (SELs), as a potential measure
of chronic disease activity outside of acute lesions in the brain. SELs were
shown to evolve independently of acute lesions leading to enhanced focal brain
tissue loss, as measured by T1 black hole evolution. Further research is
needed, but this algorithm for automatic detection of SELs using conventional
brain MRI may provide a marker of chronic disease activity in MS lesions.

“This
new ability to detect both acute and underlying disease activity with
conventional MRI may advance the way we monitor for MS progression and how we
think about overall patient management,” said Stephen Hauser, M.D., chair of
the Scientific Steering Committee of the OPERA studies, director of the Weill
Institute for Neurosciences and chair of the Department of Neurology at the
University of California, San Francisco. “While we’ve seen SELs can occur
across MS subtypes, this finding may be particularly promising for people with
primary progressive MS whose worsening of disability may be related to the
presence of SELs. This study also highlights the importance of continued
research in MS, not only for development of new treatments such as OCREVUS, but
for the insights that are gained about the fundamental cause of this
debilitating disease.”

New
data from the FLOODLIGHT clinical trial program, which is designed to assess
sensor-based outcomes from a series of active neurological tests and passive
monitoring through the use of a smartphone is also being presented. The tool
enables a continuous stream of precise, real-world MS disease progression data
to be collected and analyzed using dedicated algorithms and machine learning.

Data
at ECTRIMS – ACTRIMS demonstrate strong patient adherence to the FLOODLIGHT
technology. Hand/arm function measured with a smartphone-based pinching test
may detect subclinical impairment in those who have normal Nine-Hole Peg Test
(9-HPT) performances. Turning speed measured with a smartphone-based U-Turn
Test was shown to correlate with the Timed 25-Foot Walk (T25-FW) (p<0.001),
and may detect subclinical activity compared to normal in-clinic performances.
The data support FLOODLIGHT as a potential complement to in-clinic testing to
provide a more complete and consistent picture of a patient’s disease
progression.

OCREVUS
has been approved for use in countries across North America, South America, the
Middle East, Eastern Europe, as well as in Australia and Switzerland.

Follow
Genentech on Twitter via @Genentech and keep up to date with Joint ECTRIMS –
ACTRIMS Meeting news and updates by using the hashtag #MSParis2017.

About the OPERA I and OPERA II studies in relapsing forms of MS

OPERA
I and OPERA II are Phase III, randomized, double-blind, double-dummy, global
multi-center studies evaluating the efficacy and safety of OCREVUS (600 mg
administered by intravenous infusion every six months) compared with interferon
beta-1a (44 mcg administered by subcutaneous injection three times per week) in
1,656 people with relapsing forms of MS. In these studies, relapsing MS (RMS)
was defined as relapsing-remitting MS (RRMS) and secondary progressive MS
(SPMS) with relapses. A similar proportion of patients in the OCREVUS group
experienced serious adverse events and serious infections compared with
patients in the high-dose interferon beta-1a group in the RMS studies.

About the ORATORIO study in primary progressive MS

ORATORIO
is a Phase III, randomized, double-blind, global multi-center study evaluating
the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion
every six months; given as two 300 mg infusions two weeks apart) compared with
placebo in 732 people with primary progressive MS (PPMS). The blinded treatment
period of the ORATORIO study continued until all patients had received at least
120 weeks of either OCREVUS or placebo and a predefined number of confirmed
disability progression (CDP) events was reached overall in the study. A similar
proportion of patients in the OCREVUS group experienced adverse events and
serious adverse events compared with patients in the placebo group in the PPMS
study.

Thursday, October 26, 2017

No specific biochemical markers have been available to confirm the diagnosis of multiple sclerosis (MS) – until recently.

A Spanish and French research team developed a decision-tree based on results of analysis of biomarkers in the serum and cerebrospinal fluid (CSF) of MS patients. Lidia Fernandez-Paredes, MD (left), and Silvia Sanchez-Ramon, MD (right), both in the department of clinical immunology at Hospital Clinico San Carlos in Madrid, Spain, co-led the research team.

This lack of biomarkers often resulted in a delay in MS diagnosis and treatment while clinicians waited for a relapse to occur or for results of sequential neuroimaging studies to confirm the presence of disseminated lesions in the central nervous system. This study was conducted to provide clinicians with a means of diagnosing MS by using specific biomarkers.

In a previous, cross-sectional study in 2 independent cohorts of MS patients, the team used biologically plausible pathways to identify a panel of 12 biomarkers that might enable investigators to discriminate between the 2 main forms of MS at disease onset — relapsing-remitting MS (RRMS) and primary progressive MS (PPMS). An ability to discriminate between the 2 forms could enable clinicians to make a more specific diagnosis and provide more appropriate treatment sooner, which could delay the disease from becoming irreversibly disabling.

In the current study, the team determined which biomarkers in this panel could be most useful in diagnosing MS in the early phases of the disease as well as in predicting its course. To do this, they collected serum and CSF samples from 89 patients who were recently diagnosed with MS, 97 patients with other neurological diseases (59 non-inflammatory and 38 inflammatory), and 46 age-matched, healthy controls.

After analyzing levels of biomarkers in the samples, the team concluded that serum levels of interleukin-7 (IL-7) and C-X-C motif chemokine ligand 10 (CXCL10) appeared to provide the most accurate means of identifying large differences in disease risk. A serum IL-7 level <141 pg/mL identified patients with MS at onset (odds ratio (OR), 6.5; P < 0.001), and those who also had a CXCL10 level <570 pg/mL were at greatest risk of having the primary progressive form of MS (OR, 22; P = 0.01).

“We started this work years ago in close collaboration with Matthew Albert at the Pasteur Institute in Paris,” Sanchez-Ramon told MD Magazine. “This work is the continuation. Validating these markers at the beginning of clinical manifestations could be especially useful for making therapeutic decisions.”

In a study presented this week at ECTRIMS—the world’s largest MS research meeting—preliminary results from leading experts estimate nearly 1 million people are living with MS in the United States. This is more than twice the previously reported number, which was a result of a 1975 national study and subsequent updates. An important next step in confirming this prevalence number includes anticipated publication in a prominent medical journal.

People affected by MS, health care policy experts and researchers have long expressed the need for understanding how many people live with MS in the U.S. A scientifically sound and up to date prevalence estimate will allow us to better understand and address the needs of people with MS and accelerate our impact through advocacy and research. It can help answer such questions as the economic burden of MS on families and society, while ensuring the National MS Society is able to connect to and support all people affected by MS.

Wednesday, October 25, 2017

Exercise is an essential component of the Multiple Sclerosis
patient’s treatment plan. Unfortunately, until the 1990’s, exercise was highly
regarded as contraindicated to MS patients. In 1993, the first medicine was
approved by the FDA for MS and in 1996; the first research showing the benefits
of exercise was published by the University of Utah. These were two major
breakthroughs which have given hope to a population consisting of the most
common disabling neurological disease of young adults (most common onset
between ages 20 and 50).

Multiple Sclerosis is a neuroinflammatory autoimmune disease
of the central nervous system (CNS), consisting of the brain, spinal cord and
optic nerve. The immune system attacks
the myelin sheath of the nerves which insulates, protects as well as affects
the signal speed from the CNS to the affected body part. Presentation of
initial symptom of MS include optic nerve inflammation, poor balance (ataxia),
dizziness (vertigo), weakness, double vision (diplopia), bladder/bowel dysfunction,
pain, sensory loss, cognitive impairment, fatigue (most common) and a host of
others including but not limited to gait impairment, depression, tremors, thermo-regulatory dysfunction
(autonomic) and spasticity. Because many symptoms are invisible (not outwardly
visible), most notably fatigue, pain and cognitive impairment, they can affect
confidence, relationships, and discourage patients from seeking treatment or
help.

Currently, with more than 16 FDA approved disease modifying
treatments, as well as exercise being greatly encouraged by health care
providers treating MS, the face of MS is changing for the better. While exercise
will not change the course of the disease progression, both aerobic and
anaerobic conditioning have greatly helped reduce secondary and tertiary
symptoms such as falls, injuries, anxiety/depression, impaired activities of
daily living (secondary) and increase self-esteem, and independence while reducing social isolation
and family disruption (tertiary).

The benefits of a safe, progressive/adaptive exercise program
are improved overall fitness, ability to perform activities of daily living,
moods, sense of well-being, strength while decreasing spasticity, fatigue and
may prevent a host of co-morbidities. Because MS patients may be less mobile
and underweight/overweight, coupled with the possibility of side effects from
the use of corticosteroids, it increases the likelihood of developing
conditions such as osteoporosis and diabetes mellitus. This is an even a
greater reason those affected with MS should work with professionals who
understand the disease.

Although many patients are still hesitant to begin an
exercise program because of fear of exacerbating their condition, lack of
confidence or inability to find professionals skilled to work with them, now is
the best time in the history of MS treatment for both patients and
professionals to be on the same page. Exercise no longer has to be an activity of
an MS patient’s past. It is simply a must of the present and future.

Monday, October 23, 2017

Vitamin D deficiency represents a significant risk factor for multiple sclerosis (MS), necessitating the need for greater public outreach and interventions to improve vitamin D levels in the population, according to a case-control study published in Neurology.

Multiple sclerosis (MS) is a chronic autoimmune disease that affects the central nervous system, resulting in a variety of nonspecific neurologic symptoms.1 Bladder problems are one of the many primary symptoms of the disease and are highly prevalent among MS patients.1,2 According to results of the 2005 North American Research Committee on Multiple Sclerosis survey, 65% of MS patients have experienced at least one urinary symptom described as moderate to severe in severity.2 Additionally, analysis of the survey found that approximately 25% of MS patients perform intermittent catheterization, which significantly impacts their quality of life.

When discussing the pathophysiology of urinary retention in MS patients, it is important to consider the role of the bladder detrusor.2 The detrusor muscle is comprised of three overlapping layers of smooth muscle as well as a surrounding extracellular matrix that acts as a support. Sympathetic nervous system stimulation of alpha- and beta- adrenergic receptors relax the detrusor muscle, allowing for bladder filling and storage. Conversely, parasympathetic stimulation of muscarinic cholinergic receptors contract the muscle, causing emptying of the bladder. In patients with MS, urinary retention can be due to an underactive detrusor muscle and/or an obstruction of the bladder outlet due to detrusor sphincter dyssynergia (DSD). Both imaging and data obtained from previous studies indicate that these causes actually occur due to disruptions in neurologic signaling rather than from primary detrusor failure.

Sunday, October 22, 2017

CBD has come into the spot light throughout 2017 being acknowledged for its anti-inflammatory properties and its ability to help several intractable diseases. It has become so popular that it is now being used and researched for several conditions such as irritable bowel diseases and pain relief.

What is CBD?

CBD (Cannabidiol) is one of the natural cannabinoids found in the Cannabis Sativa plant. Unlike THC, which is known to produce a psychoactive effect, CBD does not cause a high and has, therefore, become classed as a medical compound that can treat a variety of diseases.

The Legal Status on CBD Oil

CBD oil located in stores or at least the ones you see on shelves are normally manufactured from Hemp, but if you live in a medical or recreational state, you will find CBD Oil made from the cannabis plant.

What’s the difference?

Hemp plants are grown in different conditions to marijuana plants. Hemp plants are often stalky and tall, grown aptly in fields similar to corn.

Marijuana plants are stubbier and much shorter. Marijuana is normally produced under conditions that allow for THC to be highly present among its plant constituents.

The major difference between the two is that Hemp has hardly any THC but instead other phytocannabinoids, terpenes, and CBD.

From a legal aspect, the marijuana plant is currently classed as a schedule 1 drug and therefore on a Federal level it is illegal. Individual states have introduced laws legalizing the plant and have turned into medical or recreational states. This means that if you reside in a medical state that permits the use of cannabis for specific treatments you will most likely be allowed to use CBD Oil.

But what happens if you live in a restricted state?

Obviously, CBD Marijuana Oil that will get you high is out of the questions, but CBD Hemp Oil is a completely different story. According to projectCBD.org, “Federal law prohibits U.S. farmers from cultivating hemp as a commercial crop, but the sale of imported, low-THC, industrial hemp products is permitted in the United States. This is as long as these products are derived from the seed or stalk of the plant, not from the leaves and flowers.”

Sounds amazing, right? Well, it depends on who you ask. If you read the Agricultural Farm Bill of 2014, you won’t find a clear answer on that topic. Nevertheless, what we do understand, is that companies like PureKana and GreenRoads are paving the way to alternative medical health, helping people from all 50 states by shipping their CBD Oil to patient’s doorsteps.

Whether it’s legal, or borderline, it seems to be working for millions of people over the U.S. Here are the top conditions that CBD Hemp Oil seems to be helping with.

SYMPTOMS of MS

In multiple sclerosis , damage to the myelin in the central nervous system (CNS), and to the nerve fibers themselves, interferes with the transmission of nerve signals between the brain and spinal cord and other parts of the body. This disruption of nerve signals produces the primary symptoms of MS, which vary depending on where the damage has occurred.

Over the course of the disease, some symptoms will come and go, while others may be more lasting.

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